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13 May 2019 | Story Zama Feni | Photo Charl Devenish
Dr Quinton Meyer and Marlena Visagie
National Control Laboratory Deputy Director, Dr Quinton Meyer (right), and Marlena Visagie, Quality Assurance Manager, at the laboratory within their facilities at the University of the Free State.

The University of the Free State-based National Control Laboratory for Biological Products (NCL) has maintained its esteemed status as a pharmaceutical testing laboratory after the South African Accreditation System (SANAS) further endorsed its quality-management systems as of high standard according to the International Standards Organisation’s requirements.

The Director of the NCL, Professor Derek Litthauer, said their laboratory – which is also approved by the World Health Organisation (WHO) – has again achieved the international testing standards. The cherry on top was that the NCL also received a certificate of Good Manufacturing Compliance (GMP) from the South African Health Products Regulatory Authority (SAHPRA). 

NCL is for Africa and the World 

Some of the factors that make the NCL an esteemed institution, is the fact that it is one of 12 laboratories worldwide to perform vaccine testing for the WHO; the NCL is the only vaccine-testing laboratory in the country that performs the final quality-control testing of all human vaccine batches marketed in South Africa on behalf of SAHPRA. 

For example, Prof Litthauer said that the influenza vaccine batches currently available on the South African market, were tested by the NCL for quality before authorising their release for sale to the public. This process is followed for all human vaccines used in SA.

 “In our role as vaccine-testing laboratory for the WHO, the NCL helps to ensure that the vaccines purchased through the WHO prequalification programme for international distribution to resource-limited countries, meet the high standards of quality, safety, and efficiency. 
The NCL was one of the first full members of the WHO NCL Network for Biologicals, which consists of full and associate members of regulatory authorities from more than 30 countries.

The NCL systems are world-class

Prof Litthauer said this achievement is recognition that their laboratory complies with specific international standards with respect to its quality-management system. 
“In practice, it means that the laboratory has all the quality systems in place to ensure high-quality test results. The GMP certification is a further step, meaning that laboratory testing is on the expected level for any pharmaceutical testing laboratory and manufacturer. It is a very strict certification.”

He further mentioned that the NCL is also licensed as a pharmaceutical manufacturer. “Although we do not manufacture, we have to comply with manufacturing standards.”
“It is rare for a pharmaceutical testing laboratory (such as the NCL) outside of a manufacturing context to qualify for both certifications. It means that the NCL complies with exceptionally strict standards for pharmaceutical labs anywhere in the world,” he said.
The certification provides the South African Health Products Regulatory Authority, the World Health Organisation, and other national control laboratories around the world, with the confidence that the test results from the NCL can be trusted.


There can be no compromise for quality 

The NCL Quality Assurance Manager, Mrs Marlena Visagie, said, “It is essential that the NCL complies with the highest international quality-assurance standards to ensure that all the lot-release operations, such as manufacturing review and quality testing, are performed in a reliable and reproducible manner.”

“There can be no compromise when it comes to the quality of medicines which are made available to the public,” she said.

“What makes this special, is that the NCL does not only comply with international ISO/IEC standards for pharmaceutical testing, but also with the additional GMP standards required by a pharmaceutical manufacturer. This means that the NCL must ensure that all its operations, including everything from the way documents are compiled and stored, to the maintenance of equipment and infrastructure as well as staff competency, are performed according to international guidelines.”

All NCL staff share vision of excellence

Prof Litthauer said the NCL has a staff complement of 15 technical, administrative, and support staff.  Four staff members have PhDs, and the rest of the technical staff have master’s or bachelor’s degrees or are trained as medical technologists. “At the moment, our biggest problem is to get enough suitable space to expand our testing,” he said.

Prof Litthauer said, “All the staff members at the NCL share the vision of excellence, which makes this kind of achievement possible.”
The NCL will host the third annual meeting of the WHO NCL Network in November of this year and will then be reassessed again by the WHO as part of the normal three-year cycle of assessments.  

News Archive

KovsieSport lauds its heroes of the year
2013-10-20

 

Maryka Holtzhausen and Wade van Niekerk
20 October 2013

The University of the Free State (UFS) honoured its top achievers at the Loch Logan Waterfront on Friday 18 October 2013. Maryka Holtzhausen and Wade van Niekerk were named the Sportsman and Sportswoman of the year respectively.

The Junior Sportsman and Sportswoman for 2013 are Jacques du Toit and Izelle Lategan.

This year the university’s sport stars were honored in five categories. This includes:

  • Sportsman and Sportswoman of the year (everyone that represented South Africa at a senior level, was eligible for the title). The winners each received a trophy and each sportsman and sportswomen in this category were honored with a medal.
  • Junior sportsman and sportswoman of the year. The winners each received a trophy.
  • Sport stars that represented South Africa at senior and junior level. The achievers received certificates.
  • Sport stars that represented the UFS in the national student teams. The sport stars also received certificates.
  • Certificates were also awarded to the KovsieSport club sport stars.

The following students represented South Africa at senior level:

  • Maryka Holtzhausen was a member of the Protea Netball team that participated in the Fast5 World Series in Auckland, New Zealand, in November 2012. Maryka captained the victorious Protea Netball team in the African Cup in Malawi in May 2013 and was also the captain of the Protea team that toured England in September 2013.
  • Adele Niemand was a member of the victorious Protea Netball team in the African Cup in Malawi in May 2013. Adele obtained her 50th cap for the Proteas when she played for the Protea Netball team that toured England in September 2013.
  • Izelle Lategan was a member of the SA Senior Women’s Protea team that participated in the World Hockey League Round 1 and 2, as well as in the semifinals of the World Hockey League. Izelle was also part of the Protea Women’s team that participated in the Investec Series in England.
  • Tanya Brits was a member of the SA Senior Women’s Protea team that participated in the World Hockey League Round 1 and 2, as well as in the semifinals of the World Hockey League. Tanya was also part of the Protea Women’s team that participated in the Investec Series in England.
  • Hananja Steyn was a member of the national team that participated in the African Fencing Championships in Cape Town in 2013. Hananja also participated in the World Championship in Budapest during 2013.
  • Elsabe le Roux participated in the WKF Senior World Karate Championships in Paris in 2013. Elsabe was a member of the SA Protea team that participated in the Africa Zone 6 Championships in Namibia in June 2013.
  • Diana Welmans was a member of the SA Protea team that participated in the Africa Zone 6 Karate Championships in Namibia in June 2013.
  • Elme de Villiers was a member of the SA Badminton team that won gold at the All Africa team event and she played in the semifinals in the singles at the same event. Elme also reached the quarterfinals in the singles and obtained gold in the doubles at the Mauritius Open.
  • Sandra le Grange was a member of the SA Badminton team that won gold at the All Africa team event and she obtained a bronze medal in the singles at the same event. Sandra also reached the quarterfinals and obtained gold in the doubles at the Mauritius Open.
  • Karla Mostert was a member of the Protea Netball team that participated in the Fast5 World Series in Auckland, New Zealand, in November 2012. Karla was a member of the victorious Protea Netball team in the African Cup in Malawi in May 2013 and also toured England as a member of the Protea Netball team in September 2013.
  • Balungile Ngcofe was a member of the SA Protea team that participated in the Africa Zone 6 Karate Championships in Namibia in June 2013.
  • Jan Petrus van der Merwe was a member of the SA Swimming team that participated in China and Australia during 2013.
  • Wayde van Niekerk was a member of the SA Athletics team that participated in the World Athletics Championships in Moscow, Russia, in 2013.
  • Wim Boshoff was a member of the SA Protea team that participated in the Africa Zone 6 Karate Championships.
  • Tanya Basson was a member of the SA Judo team that competed in the World Kata Championships in Italy in 2013. Tanya was a member of the SA team to compete in the Africa Championships in Maputo in 2013 and she also competed in the World Kata Championships in Japan.

Sport stars that represented South Africa on junior level, are:

  • Danelle Willemse was a member of the SA U/21 Netball team that participated in the Netball Junior World Cup in Glasgow in 2013. She also represented the SA U/21 Netball team in the World Youth Championships in Singapore in 2013.
  • Diana Welmans was a member of the SA Protea team that participated in the Africa Zone 6 Karate Championships in Namibia in June 2013. She also participated as a member of the SA U/21 team in the UFAK Africa Karate Championships in Tunisia in August 2013 where she received a bronze medal.
  • Line Malan was a member of the SA U/21 Hockey team that participated in the Hockey Junior World Cup in August 2013. She was also a member of the SA U/21 team that toured Europe in July 2013.
  • Nicole Walraven was a member of the SA U/21 Hockey team that participated in the Hockey Junior World Cup in August 2013. She was also a member of the SA U/21 Hockey team that toured Europe in July 2013. The SA U/21 team, of which Nicole was a member, won the Africa Cup Tournament in order to qualify for the Junior World Cup.
  • Cornelle Botha was a member of the SA U/21 Hockey team that toured Europe in July 2013. The SA U/21 team, of which Cornelle was a member, won the Africa Cup Tournament in order to qualify for the Junior World Cup.
  • Lisa Hawker was a member of the SA U/21 Hockey team that won the Africa Cup Tournament.
  • Izelle Lategan was not only a member of the SA U/21 Hockey team that participated in the Hockey Junior World Cup in August 2013, but also captained the team. She also captained the SA U/21 Hockey team that toured Europe in July 2013 and won the Africa Cup Tournament in order to qualify for the Junior World Cup. Izelle’s outstanding performances was recognised by SAHA when she was announced as the SA Junior Hockey Player. She was also a member of the SA Senior Women’s Protea team that participated in the World Series Hockey League.
  • Tanya Brits was a member of the SA U/21 Hockey team that participated in the Hockey Junior World Cup in August 2013. She was also a member of the SA U/21 Hockey team that toured Europe in July 2013 and won the Africa Cup Tournament in order to qualify for the Junior World Cup. Tanya was also a member of the SA Senior Women’s Protea team that participated in the World Series Hockey League.
  • Jacques du Toit was a member of the SA U/21 Rugby team that participated in the IRB Junior World Championships in 2013.
  • Andries Gous played as a SA U/19 Cricket player in a test series against England in January and February 2013, as well as in the One-Day Series against England during February and March 2013.
  • Wim Boshoff participated as a member of the SA U/21 team in the UFAK Africa Karate Championships in Tunisia in August 2013 where he received a bronze medal. He also participated in the Istanbul Open in Turkey in September 2013.

The KovsieSport club sport stars are:

  • Maryka Holtzhausen – Netball
  • Jaco Fourie – Hockey
  • Izelle Lategan – Hockey
  • Leonard Killeen – Cricket
  • Teboho (Oupa) Mohoje – Rugby
  • Duke Munro – Tennis
  • Christi Potgieter – Tennis
  • Ricco Sutil – Soccer
  • Choaro Khumisi – Soccer
  • Wayde van Niekerk – Athletics
  • Danelle Prinsloo - Athletics

B Category:

  • Jan Petrus van der Merwe – Aquatics
  • Elsabe le Roux – Karate
  • Tanya Basson– Judo

The USSA international participants were:

  • Wayde van Niekerk participated in the World Student Athletic Games in Russia in July 2013.
  • Gideon Trotter participated in the World Student Athletic Games in Russia in July 2013.
  • Rynhardt van Rensburg participated in the World Student Athletic Games in Russia in July 2013.
  • Dumisane Hlaselo participated in the World Student Athletic Games in Russia in July 2013.
  • Jaco Fourie participated in the World Student Hockey Games in Russia in July 2013.
  • Luke Sanan participated in the World Student Hockey Games in Russia in July 2013.
  • Robbie van Schalkwyk participated in the World Student Rugby Games in Russia in July 2013.
  • Elme de Villiers participated in the Student World Badminton Championships in Korea in November 2012.
  • Sandra le Grange participated in the Student World Badminton Championships in Korea in November 2012.

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